Multiflex Steerable Sheath 17.5F

The Vizaramed Multiflex Steerable Sheath 17.5F is a deflectable, single-use catheter introducer sheath designed to guide various cardiovascular catheters into the heart, including access to the left side of the heart through the interatrial septum. It features a steerable shaft capable of complex three-dimensional shapes, a lockable handle with steering controls, a Tuohy-Borst adapter with hemostasis valve, side port with 3-way stopcock, and a soft distal tip that is radio-opaque for fluoroscopic visualization.

The 17.5F sheath represents a modest dimensional increase from the 15.5F predicate device, using identical materials and construction methods. It accommodates devices from 3F to 17.5F in diameter and employs the same sterilization method (ethylene oxide per ISO 11135) as the predicate. The design maintains the same fundamental intended use, technological characteristics, and risk profile as the predicate 15.5F model.

ISO 11135 for ethylene oxide sterilization validation; ISO 14971 for risk analysis; ISO 13485 for quality management system requirements. Mechanical testing included tensile strength, kink resistance, and deflection testing. Biocompatibility testing covered cytotoxicity, sensitization, irritation, acute systemic toxicity, material-mediated pyrogenicity, and hemocompatibility.

Substantial equivalence is supported by: identical indications for use; identical materials and construction to the predicate 15.5F Multiflex Steerable Sheath (K221655); proportional dimensional increase with no new hazards identified under ISO 14971 risk analysis; all mechanical and functional testing meeting acceptance criteria; and established safety precedent for larger bore Class II catheter introducers up to 24.0F (K203670) previously cleared by FDA.